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To facilitate the submission of regulatory information concerning marketing authorisations application for medicinal products to National Competent Authorities and EMA as well as to streamline the business process, standards for electronic submissions have been developed.
For human medicinal products, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed an electronic exchange standard called electronic Common Technical Document (eCTD). This standard is based on “M4: The Common Technical Document (CTD)” in its various parts.
The current electronic version was developed by the eCTD Implementation Working Group and released as version 3.2 in February 2004. The European Union applies the eCTD Specification in the European region and has completed it with the European Module 1.
Preparation of the next major version (version 4.0) is now ongoing within the ICH.
For more information, please refer to the eCTD v.3.2, eCTD EU M1 specification and eCTD v.4.0 webpages.
For veterinary medicinal products, a specific EU standard, Veterinary Non-eCTD electronic Submissions (VNeeS), that is based on the EU Notice to Applicants format for veterinary applications, has been developed.
For more information, please refer to the Veterinary eSubmission webpage.
The EU standards and related guidance documents are developed and maintained by the different key user groups and approved by the eSubmission expert group before publication.
For technical support, visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here.
For details on how to find us please click here.
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What's New in eSubmission Today? |
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01-06-2023
eSubmission Gateway XML delivery file update for obsolete Veterinary submission types
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file for Veterinary submissions (removal of obsolete submission types: extension, var-type1b, var-type2 and vet-psur).
The details on the changes are provided in the related release notes which are available here and the updated user guide is available here.
30-05-2023
Planned maintenance of the eSubmission systems on 31 May 2023
Due to planned maintenance of the eSubmission systems on Wednesday 31 May 2023, the Delivery File UI and the Gateway FileHandler will be unavailable between 18:00 and 20:00. During this time, submissions uploaded through Syncplicity will not be processed, therefore avoid sending submissions during this maintenance window. For any further information, please contact Service Desk
And
Updated version of the eAF v1.26.0.0 (human variation)
An updated version 1.26.0.0 of the human variation eAFs will be available starting with 31 May 2023, 20:00.
A single change has been implemented to address a non-blocking bug. There is a very limited impact to users of the forms. The use of the v1.26.0.0 is mandatory since 1st January 2022 (human).
It is recommended to use this latest form for new submissions (document properties date 25.05.2023), however you can finalise the existing forms (if any) in the previous version. Please note that there is no version number change and that the release notes are not published for this minor change at this time.
17-05-2023
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.8 released to production on the 16th of May 2023 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
16-05-2023
eAF-PMS Newsletter Issue 3
We are pleased to announce the third edition of the eAF-PMS newsletter is now available at the following link.
This newsletter, available to pharmaceutical companies and National Competent Authorities (NCAs), offers updates on the progress of eAF and PMS, presenting an overview of past and future activities.
In particular, we would like to highlight the following topics:
Upcoming webinars (more details on single events are available in the newsletter):
- Product Lifecycle Management (PLM) Portal Access Management Training Session (25 May 2023, 11:00 - 12:30 Central European Summer Time (CEST)): registration link
- Product Management Service (PMS) Progress Webinar (30 May 2023, 10:00 - 11:30 CEST): registration link
- eAF-PMS Joint Webinar on Nationally Authorised Products (NAPs) Data Release on PLM Portal eAF (8 June 2023, 10:00 - 11:30 CEST): registration link
Updated documents:
Human Variations eAF-PMS Frequently Asked Questions (FAQs) document
Please send any questions to eSubProgofficer@ema.europa.eu or via the PLM Portal Forum.
10-05-2023
eAF PDF working as expected
The selection of active substances is now possible and eAF PDF is working as expected. Should you encounter any issues, please raise a ticket in EMA Service Desk (https://support.ema.europa.eu/esc).
08-05-2023
eAF PDF not working as expected
Please note the eAF PDF is not working as expected (the active substances cannot be selected from the database). Our colleagues are working on fixing the issue and once the eAF PDF will be fully functional, a message will be posted on this page and the users who have raised a related ticket in EMA Service Desk will be contacted as soon as possible.
24-04-2023
Web-based Human Variations eAF (DADI) - Updated timeline
We are pleased to inform you the updated PLM (Product Lifecycle Management) Portal web-based electronic Application Form (eAF) for Human medicinal products release timeline is available on the PLM portal Forum at the following link. In addition, we invite PLM Portal users' feedback on the Portal and web-based eAFs through a survey you can find below.
Note in particular the following periods:
| June 2023 |
Start of data transfer - Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs) for use in eAFs - the first NAPs products will appear in the eAF. This will allow users to start preparing web-based eAFs for NAPs as these products become gradually available on the PLM Portal; |
| August 2023 |
Expected completion of data transfer - all CAPs and NAPs available in eAF; |
| November 2023 |
User Acceptance Testing (UAT) on the version of the web-based eAF intended to replace the PDF and trigger the transition; |
| Q1 2024 |
Confirmation of transition period start date, approximately 2 months in |
| Q2 2024 |
Start of 6-months transition to mandatory use of web-based eAF for Human Variations. This is subject to a successful outcome of the UAT. Note that the transition period may start earlier, if feasible, respecting the 2- month advance notice period. |
(Further detailed information on impacts for eAF Users, can be found in the 2nd page of the document link.
Please note:
- Functionalities required for mandatory use are being released incrementally: all required functionalities will be available on the PLM Portal before the start of the UAT.
The use of the web-based eAF will follow the current process for updating data. Use of structured data will be implemented at a later point.
The capability to view migrated PMS product data in the Product User Interface on the PLM Portal is under development in parallel - delivery timelines will be announced at a later date.
Details on how the UAT will be organized will be shared in due course.
and
24-04-2023
Feedback Survey for PLM Portal Users (New Deadline: 8 May 2023)
We kindly ask you to provide your feedback on your experience with the new eAF and the PLM Portal, by responding the survey at the following link: https://ec.europa.eu/eusurvey/runner/Adoption-survey-eAF-HumanVariations
This survey aims to gather your feedback on the level of adoption of the change, including the potential concerns or issues you are facing, in order to enable the eAF product team to envisage appropriate fixing and/or mitigation activities.
Please note that the survey will be anonymous, and the results will not be publicly disclosed.
This survey was already shared with PLM portal users in March 2023 and was intended to close on 31 March 2023, but the deadline for responding is now extended to 8 May 2023.
For more insight on eAF, you are invited to consult the following Q&A documents and sessions:
Training Q&A document (link) addressing questions raised by users during earlier eAF (DADI) trainings;
Human Variations eAF go-live Q&A session (link);
Human Variations eAF go-live training session (2 February 2023) (link).
eSubProgofficer@ema.europa.eu or via the PLM Portal Forum.
19-04-2023
Updated PLM Portal eAF timeline now available
Please find an updated version of the PLM Portal eAF Human Variations Forms timeline. The slide is also available on the PLM Portal Forum.
11-04-2023
PSUR unavailable this Tuesday evening
Due to essential maintenance, PSUR will be unavailable on Tuesday 11 April 2023 between 18:00 and 20:30 (CET). For any questions or concerns, please log a ticket via the EMA Service Desk
21-03-2023
Feedback Survey for PLM Portal Users (Deadline: 31 March 2023)
Following the launch of the Human Variation electronic Application Form (eAF) for Centrally Authorised Products (CAPs) on the Product Lifecycle Management (PLM) Portal, we appreciated many users have accessed the PLM Portal to work on variation applications using the new web-form.
We kindly ask you to provide your feedback on your experience with the new eAF and the PLM Portal, by responding the survey at the following link: https://ec.europa.eu/eusurvey/runner/Adoption-survey-eAF-HumanVariations
This survey aims to gather your feedback on the level of adoption of the change, including the potential concerns or issues you are facing, in order to enable the eAF product team to envisage appropriate fixing and/or mitigation activities.
Please note that the survey will be anonymous and the results will not be publicly disclosed. The survey will stay open until 31 March 2023.
This should not take more than 5 minutes.
17-03-2023
Common Repository Go-Live on 20th of March 2023 (relevant for NCAs only)
We are pleased to inform you that the next version of the Common Repository introducing the 'Basic Authentication' is going live on the 20th of March 2023 (originally planned for the 14th of March). This release improves security by modifying access to the Common Repository requiring all users to log in to the system to view/download submissions. Additionally, this release provides usability improvements mainly related to procedures containing Nationally Authorised Products.
And
Common Repository UI and API and eSubmission Delivery File UI will be unavailable on Monday evening
Common Repository UI and API and eSubmission Delivery File UI will be unavailable on Monday evening.
Due to planned maintenance, Common Repository UI and API and eSubmission Delivery File UI will be unavailable on Monday evening, 20th of March 2023 between 17:30 and 20:30 (CET). For any further information, please contact Service Desk
And
Planned maintenance of the eSubmission systems on Saturday 25 March 2023
The eSubmission systems are unavailable for planned maintenance and will be unavailable from Saturday 25th of March 2023 08:00 until 18:00 due to essential maintenance. For any further information, please contact Service Desk
14-03-2023
Common Repository Go-Live (relevant for NCAs only)
We are pleased to inform you that the next version of the Common Repository introducing the ‘Basic Authentication’ is going live on the 14th of March 2023. This release improves security by modifying access to the Common Repository requiring all users to log in to the system to view/download submissions. Additionally, this release provides usability improvements mainly related to procedures containing Nationally Authorised Products.
For the completion of the deployment, Common Repository UI and API and eSubmission Delivery File UI will be unavailable this Tuesday evening, 14th of March 2023 between 18:30 and 19:30 (CET).
09-03-2023
Updated variation FHIR mapping and conceptual data models
The Variation FHIR mapping and the conceptual data models have been updated and are now available here.
08-03-2023
eAF-PMS FAQs Document Publication
The eAF and PMS teams are pleased to announce that an eAF-PMS FAQs Document is now available here. This document contains Frequently Asked Questions on eAF and PMS and will be updated regularly.
28-02-2023
Common Repository and eSubmission Logs unavailable this Tuesday evening
Due to essential maintenance, Common Repository and eSubmission Logs, will be unavailable on Tuesday 28 February 2023 between 18:00 and 20:00 (CET). For any questions or concerns, please log a ticket via the EMA Service Desk
And
PSUR unavailable this Wednesday evening
Due to essential maintenance, PSUR , will be unavailable on Wednesday 01 March 2023 between 18:00 and 20:00 (CET). For any questions or concerns, please log a ticket via the EMA Service Desk
22-2-2023
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.6 released to production on 21st of February 2023 are now available on PLM Portal Forum and on the PLM Portal eAF (DADI) web page.
24-1-2022
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.4 released to production on 23rd January 2023 are now available on the PLM Portal Forum and on the PLM Portal eAF (DADI) web page.
And
Updated PLM Portal Guide to Navigation is now available
Please find an updated version of the PLM Portal eAF Guide to Navigation here. The slide is now available on the PLM Portal Forum and on the PLM Portal eAF (DADI) web page.
And
eAF - PMS Newsletter Issue 2
We are pleased to inform you that the second edition of the eAF (DADI)-PMS Newsletter is published and available on the EMA corporate website here.
The eAF-PMS Newsletter, published four times a year, provides pharmaceutical companies and the national competent authorities in the EU updates on the progress of the eAF and PMS products.
It also includes an overview of upcoming events and information on available resources.
For more insight on eAF, you are invited to register to the upcoming events and consult the following resources:
Upcoming events:
- Human Variations eAF Q&A Clinics:
- Human Variations eAF public training:
Q&A documents:
- General Q&A Document (link), including Q&A's on PMS (Product Management Services);
- Training Q&A document (link) addressing questions raised by users during earlier eAF (DADI) trainings.
- Human Variations eAF go-live Q&A session (link).
- Human Variations eAF go-live training session (8 November 2022) (link).
Please send any questions to eSubProgofficer@ema.europa.eu
21-12-2022
Updated draft eCTD v4.0 implementation timeline for EU now available
An updated draft timeline for the implementation of eCTD v4.0 in the EU is now available on the eCTD v4.0 page here.
And
Updated PLM Portal eAF timeline now available
Please find an updated version of the PLM Portal eAF (DADI) Human Variations Forms timeline. The slide is now available on the PLM Portal Forum and on the PLM Portal eAF (DADI) web page.
And
Updated PLM Portal Guide to eAF (DADI) Registration is now available
An updated version of the Portal (eAF) guide to registration is now available on the PLM Portal Forum and on PLM Portal eAF (DADI) webpage. The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the PLM Portal. This update includes several updates across the document.
For any issues or technical support on PLM Portal, please raise a ticket with the EMA Service Desk portal. Please share any questions with us via eSubProgofficer@ema.europa.eu.
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.
